Cabotegravir And Rilpivirine: Efficacy and Safety Study

Project Summary

What is CARES?

Cabotegravir And Rilpivirine: Efficacy and Safety Study (CARES) is a research project that aims to make taking medication easier for people living with HIV in sub-Saharan Africa. Many people on combination anti-retroviral therapy (cART) must take many pills each day to maintain their health and well-being. CARES offers an alternative: injectable medication taken 6 times per year. Because this regimen offers the benefit of reduced dosing from daily pills to injections every 2 months, the study is expected to demonstrate whether this could have a positive impact on the patient’s quality-of-life, improve adherence to treatment, improve engagement in care and reduce the stigma associated with the daily use of oral pills.

How does it work?

randomized clinical trial is currently underway in three sub-Saharan African countries (Kenya, South Africa, and Uganda) to demonstrate the safety and efficacy of taking injectable anti-retroviral treatment every two months instead of taking oral medicine each day in virologically suppressed adults for a period of 24 months.

The project started enrolling participants on 15th September 2021.  Adults living with HIV (n=512) were randomly selected to continue taking first-line cART or asked to start taking injectable, long-acting Cabotegravir and Rilpivirine (CAB + RPV LA)

The primary aim of CARES is to show that switching to injectable medicine works just as well as taking pills for HIV treatment in a resource limited setting.

Secondary aims are:

  1. To demonstrate the antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 2 months compared to continuation of cART over 12 and 24 months of follow-up.
  2. To evaluate the safety and tolerability of switching to IM CAB LA+RPV LA every 2 months compared to continuation of cART.
  3. To assess viral resistance in participants experiencing protocol-defined confirmed virologic failure (plasma HIV-1 RNA ≥200 c/mL).
  4. To assess the incidence of on-treatment genotypic resistance to CAB, RPV and other on-study cART up to Month 12and 24.
  5. To evaluate adherence to treatment.

Who is part of CARES

The CARES project screened over 1000 participants across 3 clinic sites in Kenya, 3 clinic sites in Uganda, and 2 clinic sites in South Africa to enroll 512 participants. The study is a collaborative effort between research teams sponsored by JCRC Uganda funded by Janssen.

History of ART